To Evaluate The Similarity Of In Vitro Dissolution Of Homemade Misoprostol And Its Original Preparation

Objective:To establish a method for determining the dissolution curve of misoprostol tablets in China,a new method was used to determine the dissolution of misoprostol tablets from 4 domestic manufacturers of with different pH values,draw the corresponding dissolution curve,compare their similarity,and study the bioequivalence of drugs。Methods:Using the Chinese Pharmacopoeia(2015 Edition Four)dissolution determination method second large cup method,pH1.2 hydrochloric acid solution,pH4.5 phosphate buffer,pH6.8 phosphate buffer and water were used as dissolution medium,medium volume each 500ml,take up supernatant at different time,measure the peak area with HPLC method,calculate the dissolution rate,draw four manufacturers misoprostol tablets in vitro dissolution curve,using f 2 similarity factor method considering the similarity。Results:Verification of the method validation requirements in accordance with the Chinese Pharmacopoeia(2015 Edition Four),the results conform to the requirement of pharmacopoeia.in the study of the dissolution curve similarity,there was significant difference between A and B in the dissolution curve of the original agent,the dissolution curve of C and D was similar to that of the original one。Conclusion:The new method for determining the dissolution curve of misoprostol tablets in China is more common,It is recommended to improve its quality standards.in the bioequivalence of drugs,there were significant differences in quality between A and B manufacturers in the production of drugs,should improve the process conditions and improve the quality of drugs,the dissolution curve of C and D was similar to that of the original preparation,reflect the C and D manufacturer the products with the original development of agent internal quality difference is smaller.